NCT04975997 · CITED IN SOURCE DOCUMENTS

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-04-03

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria * Documented diagnosis of multiple myeloma (MM) and measurable disease. * Received 1 to 2 prior lines of anti-myeloma therapy. * Must have documented disease progression during or after their last anti-myeloma regimen. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2. Exclusion Criteria * Any condition that confounds the ability to interpret data from the study. * Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis. * Known central nervous system involvement with MM. * Prior therapy with iberdomide. * Other protocol-defined Inclusion/Exclusion criteria apply.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.
intervention Names
Drug: Dexamethasone
Drug: Daratumumab
Drug: Iberdomide
label
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
type
EXPERIMENTAL
intervention Names
Drug: Dexamethasone
Drug: Daratumumab
Drug: Iberdomide
label
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
type
EXPERIMENTAL
intervention Names
Drug: Dexamethasone
Drug: Daratumumab
Drug: Iberdomide
label
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
type
EXPERIMENTAL
description
Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone
intervention Names
Drug: Dexamethasone
Drug: Bortezomib
Drug: Daratumumab
label
Daratumumab in combination with dexamethasone and bortezomib
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
Daratumumab in combination with dexamethasone and bortezomib
description
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
name
Dexamethasone
type
DRUG
arm Group Labels
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
description
Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7+ of a 28-day cycle
name
Daratumumab
other Names
DARZALEX FASPRO
type
DRUG
arm Group Labels
Daratumumab in combination with dexamethasone and bortezomib
description
Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.
name
Bortezomib
type
DRUG
arm Group Labels
Daratumumab in combination with Iberdomide and dexamethasone - Dose 1
description
Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle
name
Iberdomide
other Names
CC-220
BMS-986382
type
DRUG
arm Group Labels
Daratumumab in combination with Iberdomide and dexamethasone - Dose 2
description
Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle
name
Iberdomide
other Names
CC-220
BMS-986382
type
DRUG
arm Group Labels
Daratumumab in combination with Iberdomide and dexamethasone - Dose 3
description
Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle
name
Iberdomide
other Names
CC-220
BMS-986382
type
DRUG
arm Group Labels
Daratumumab in combination with dexamethasone and bortezomib
description
Oral dexamethasone 20mg on days 1,2, 4,5,8,9,11,12 of a 21-day cycle from cycles 1-8
name
Dexamethasone
type
DRUG
arm Group Labels
Daratumumab in combination with dexamethasone and bortezomib
description
Subcutaneous daratumumab 1800mg Cycles 1 to 3 on Days 1, 8, 15 of a 21-day cycle, Cycles 4 to 8 on Day 1 of a 21-day cycle and Cycles 9+ on Day 1 of a 28-day cycle.
name
Daratumumab
other Names
DARZALEX FASPRO
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 939
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of progression free survival (PFS).
measure
Progression-free Survival (PFS)
time Frame
Up to approximately 5 years
description
To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of minimal residual disease (MRD) negative complete response (CR) at any time.
measure
Minimal Residual Disease (MRD) negative Complete Response (CR) at any time
time Frame
Up to approximately 5 years

secondary Outcomes

description
To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).
measure
Overall Survival (OS)
time Frame
Up to approximately 5 years
description
To evaluate the sustainability of minimal residual disease (MRD) negativity.
measure
Sustainability of Minimal Residual Disease (MRD) negativity
time Frame
Up to approximately 5 years
description
Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.
measure
Overall Response Rate (ORR)
time Frame
Up to approximately 5 years
description
Time from randomization to the first documentation of response (PR or better).
measure
Time to response (TTR)
time Frame
Up to approximately 5 years
description
Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.
measure
Duration of Response (DoR)
time Frame
Up to approximately 5 years
description
The time from randomization to the first documented disease progression.
measure
Time to Progression (TTP)
time Frame
Up to approximately 5 years
description
Time from randomization to the start of the next antimyeloma treatment.
measure
Time to Next Treatment (TTNT)
time Frame
Up to approximately 5 years
description
Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.
measure
Progression-free Survival 2 (PFS2)
time Frame
Up to approximately 5 years
description
Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.
measure
Safety
time Frame
Up to approximately 5 years
description
Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.
measure
European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)
time Frame
Up to approximately 5 years
description
EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.
measure
European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)
time Frame
Up to approximately 5 years
measure
Recommended iberdomide dose for Stage 2
time Frame
Up to approximately 1 year

Full study description

brief Summary: This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).
detailed Description: This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B). In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms: * Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd) * Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd) Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment. The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

Source references

references

citation
Lonial S, Dimopoulos MA, Berdeja JG, Richardson PG, Quach H, Rodriguez-Otero P, Maciag P, Hong K, Amatangelo M, Chen M, van de Donk NWCJ. EXCALIBER-RRMM: a phase III trial of iberdomide, daratumumab, and dexamethasone in relapsed/refractory multiple myeloma. Future Oncol. 2025 Jun;21(14):1761-1769. doi: 10.1080/14796694.2025.2501920. Epub 2025 May 10.
pmid
40346992
type
DERIVED